COPD患者のドロナビノールによる息切れの軽減 (BONG)
BONG：重度および超重度の慢性閉塞性肺疾患患者グループにおけるドロナビノールによる重度の息切れの軽減 - 無作為化、二重盲検、プラセボ対照、クロスオーバー研究
This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).
調査の概要
詳細な説明
This study is a randomized, controlled, double-blind, crossover trial evaluating the effectiveness of the pharmaceutical drug Dronabinol in patients with severe and very severe COPD.
The researchers will compare the effects of Dronabinol with a placebo (an identical-looking substance that contains no active drug) to determine if Dronabinol reduces breathlessness in COPD patients.
After enrollment, study subjects will undergo four weeks of treatment with both Dronabinol and the placebo in a blinded and randomized sequence. There is a two-week washout period between treatments. During these treatment phases, subjects will complete questionnaires about their daily experiences of breathlessness and wear a watch that records various health parameters.
The study includes eight visits: the initial enrollment and follow-up checks every two weeks. At these visits, subjects undergo tests for lung function and walking distance, and complete health status questionnaires. Additionally, blood samples for THC levels and hair samples for cortisol analysis are collected.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Region Syddanmark
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Vejle、Region Syddanmark、デンマーク、7100
- Vejle Hospital - A part of Lillebaelt Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Refractory dyspnea despite optimal treatment
- COPD (GOLD 3,4)
- Breathlessness corresponding to mMRC score ≥ 3
- Informed written consent
- Age ≥ 18 years
- Cognitive relevant, of legal age
- Understands and speaks Danish
- For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial
- For fertile and sexually active subjects: use of safe contraception during medication intake and 4 weeks after: intrauterine device (IUD) or hormonal contraception (oral contraceptive pill, implant, transdermal patch, vaginal ring or depot injection).
Exclusion Criteria:
- Ongoing infection or exacerbation of COPD within the last month (30 days)
- Regular treatment with THC or CBD within 1 month (30 days)
- Life expectancy less than 3 months (90 days)
- Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19
- History of or current evidence of significant medical or psychiatric disorder that is considered by the investigator to put the subject at greater risk of experiencing an adverse event
- Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Dronabinol 20 mg, then placebo
In this arm, the study subject will first receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
他の名前：
Dronabinol-matched placebo capsule containing no active substance. |
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プラセボコンパレーター：Placebo, then dronabinol 20 mg
In this arm, the study subject will first receive placebo capsules (matching dronabinol 2.5 mg capsules). For two weeks the subject will titrate with one capsule every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 8 daily placebo capsules over a period of 2 weeks. After a wash out period of 2 weeks, study subject will receive dronabinol 2.5 mg capsules. For two weeks the subject will titrate dose with one capsule corresponding to 2.5 mg dronabinol every other day until 20 mg. Doses are divided into three times a day. After up titration the subject will receive 20 mg daily treatment over a period of 2 weeks. |
Dronabinol 2.5 mg pr capsule. Titration up till 20 mg daily dose.
他の名前：
Dronabinol-matched placebo capsule containing no active substance. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in Numeric Rating Scale score of discomfort of daily breathlessness between active treatment and placebo
時間枠：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Difference in Numeric Rating Scale score of breathlessness interference of daily activities between active treatment and placebo
時間枠：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
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Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
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Correlation between breathlessness rated on a daily numeric rating scale in relation to amount of THC blood level of the active treatment period
時間枠：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects higher discomfort of breathlessness |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
|
Correlation between breathlessness interference of daily activities rated on a numeric rating scale in relation to amount of THC blood level of the active treatment period
時間枠：Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
Numeric rating scale score range 0-10. Higher score reflects more breathlessness interference on daily activities |
Assessed daily in the baseline period and through both treatment periods. Up to 70 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in Multidimensional Dyspnea Profile questionnaire score between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assesses different dimensions of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in COPD Assessment Test questionnaire score between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assesses the severity of physical COPD symptoms. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Chronic Respiratory Disease Questionnaire score between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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A HRQL tool which incorporates patient perceptions of both physical and emotional health. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Hospital Anxiety and Depression Scale questionnaire score between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assess anxiety and depression symptoms in medical patients. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Medical Research Council Dyspnea Scale questionnaire score between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
|
A simple and valid method of categorizing patients with COPD in terms of their disability that could be used to complement FEV1 in the classification of COPD severity. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in Epworth Sleepiness Scale questionnaire score between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Assesses person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in the spirometry parameter forced expiratory volume in 1. second (FEV1) between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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The FEV1 indicates the lung tissue's ability to release air during the first second of exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in the spirometry parameter forced vital capacity (FVC) between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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The FVC indicates the lung tissue's ability to release air during the entire exhalation. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in the spirometry parameter FEV1/FVC (ratio), between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Can indicate an obstructive pattern in the exhalation which are used in the diagnosis of COPD. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in six-minute walk test(6MWT) between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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6 minutes walking test measures breathlessness and performance ability. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference Borg dyspnea score conducted in relation to 6MWT between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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A numeric scale from 0 (no breathlessness) to 10 (extremely strong breathlessness) but not limited to 10 if subjects feel breathlessness above 10 |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in cortisol level in the hair samples between active treatment and placebo period
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Measurement of stress through cortisol levels in the hair. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Difference in clinical parameters between active treatment and placebo period using a yet unspecified continuous monitoring device.
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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For several days in each treatment period we continuously measure blood oxygen saturation, electrodermal activity, pulse rate, sleep recording, temperature, respiratory rate, and activity counter. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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Difference in stand-to-sit-test between active treatment and placebo
時間枠：Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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A measurement for physical capability until breathlessness. |
Baseline (T1; day 1) and after each treatment period (T4; day 28, T7; day 70)
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Ole Hilberg, Prof., MD、Medical Department, Vejle Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2024-513593-22-00
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
It is the plan to share SAP when this is finalized. It is undecided whether CSR and analytic code will be shared on a platform or available on reasonable request.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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